Clinical Outcomes Solutions
Clinical Outcomes Solutions
Clinical Outcomes Solutions farmatsevtika va biotexnologiya tashkilotlari uchun klinik natijalarni baholash (COA) tadqiqotlariga ixtisoslashgan global konsalting kompaniyasidir. Uning jamoasi bemorlarning tajribasi haqida ishonchli ma’lumotlarni to‘plash uchun tadqiqot strategiyalari va amaliy yechimlarni ishlab chiqadi hamda mijozlarga klinik natijalar bilan bog‘liq ishlarning ilmiy va me’yoriy murakkabliklarini hal qilishda yordam beradi. Kompaniya tadqiqotlarni loyihalash va dalillarni shakllantirish jarayonlariga bemorlar fikrini kiritish orqali asoslangan tibbiy yordam qarorlarini va bemorlar uchun yanada yaxshi natijalarni qo‘llab-quvvatlaydi.

Principal Biostatistician, FSP – UK Remote

Provide biostatistical support across Phase I–IV clinical trials and regulatory submissions for Cytel’s pharmaceutical clients. Develop SAPs, analyze clinical data, and contribute to integrated clinical study reports.

Tavsif

  • Support Phase I–IV clinical studies
  • Conduct ad hoc and exploratory analyses for submissions and Health Authority questions
  • Provide statistical guidance throughout clinical studies
  • Contribute to protocol development, study design discussions, and sample size calculations
  • Review CRFs and data review guidelines
  • Create statistical analysis plans, including analysis dataset and TLG specifications
  • Execute statistical analyses and interpret the findings
  • Prepare clinical study reports, including integrated submission summaries
  • Explain statistical methods and the implications of key decisions
  • Work fully embedded with a global pharmaceutical client while receiving support from Cytel
  • Partner with clinical, regulatory, programming, internal, and external teams

Talablar

  • Master’s degree in statistics or a related field
  • At least 3 years of clinical-trial support experience in the pharmaceutical or biotechnology industry
  • CRO experience is strongly preferred
  • Experience with sample size calculations, protocol concept and protocol development, SAPs, and clinical study reports with integrated submission summaries
  • Strong SAS programming skills for quality control of critical outputs and efficacy and safety tables, with the ability to work closely with programmers
  • Strong understanding and practical application of CDISC requirements for regulatory submissions
  • Proficiency in generating ADaM specifications and performing dataset quality control
  • Ability to build effective external and internal relationships and motivate regional or global teams
  • Clear communication skills, including the ability to explain methodologies and decision implications in plain language
  • Knowledge of R programming is advantageous
  • Regulatory work experience is an advantage

Imtiyozlar

  • Ongoing training, development, and support
  • Strong opportunities for professional growth
  • Professional development opportunities

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